MalfunctionFPB
VYGON TPN FILTER
Received Aug 1, 2025 · Event occurred Jun 30, 2025
Report 22687174 · MDR key 22687174
Device
Product problems
- Crack
- Leak/Splash
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
BEDSIDE RN FOUND THE PATIENT'S TPN FILTER WAS LEAKING BETWEEN THE CONNECTION OF THE FILTER AND THE TPN TUBING ALTHOUGH THE CONNECTION WAS SECURED. THE CONNECTION WAS TIGHT AND THERE WAS NO NOTICEABLE CRACK/DAMAGE TO THE FILTER/TUBING. BEDSIDE RN CALLED INPATIENT PHARMACY, AND THEY SENT UP A NEW FILTER. IT STOPPED LEAKING ONCE THE FILTER WAS CHANGED.